BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE RELOAD FOR ECHELON 60

    MDR report key: 1812288 · Received August 24, 2010

    Report

    Report Number
    3005075853-2010-04810
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, ALTHOUGH THE DEVICE COULD BE FIRED AT THE FIRST STROKE OF THE FIRST FIRING, THE CARTRIDGE SLID FORWARD AT THE SECOND STROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE NURSE COMMENTED THAT THE DEVICE HAD BEEN LOADED PROPERLY SO THAT THE CLICK SOUND WHICH WOULD BE HEARD WHEN THE CARTRIDGE WAS LOADED PROPERLY HAD BEEN HEARD. THE CUSTOMER DISPOSED OF THE DEVICE, NO DEVICE WILL BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1